Sanofi, armed with more strong PhIII dengue data, sets sights on 2015 rollout

Sanofi Pasteur CEO Olivier Charmeil

Expanded results from Sanofi's ($SNY) Latin American Phase III dengue vaccine trial are here, and the pharma giant says they confirm the high efficacy against severe dengue and the reduction in hospitalization the jab posted in its first Phase III study. And with these in tow, the company says it could have the vaccine to market by the second half of next year.

The results, published in The New England Journal of Medicine, show that Sanofi's candidate posted 95% efficacy against dengue hemorrhagic fever, a severe form of the disease, and an 80.3% reduction in the risk of hospitalization. Those data support an 88.5% cut in hemorrhagic fever and a 88.5% hospitalization reduction the shot put up in a study of 10,275 children across Asia.

All things considered, the company said in a statement that its dengue vaccine--set to become the world's first--could be available in the second half of 2015. "We plan to submit the vaccine for licensure in 2015 in endemic countries where dengue is a public health priority," Olivier Charmeil, CEO of Sanofi's vaccines division, said in a statement.

Former Sanofi CEO Chris Viehbacher

As then-CEO Chris Viehbacher said on a call with investors last week, selling the vaccine--which analysts predict could rack up €1 billion ($1.31 billion) a year--is "largely going to be a government contracting approach." The French drugmaker has built a model that predicts the incidence of dengue based on the vaccinated population, and Sanofi is "working through country by country" to help public health authorities figure out "what is the right vaccination cohort, what is the right amount to spend upfront," he said.

Of course, Viehbacher won't be the one presiding over the vaccine's rollout now that Sanofi has sent him packing. Frenchman Olivier Bohuon, CEO of artificial hip and knee maker Smith & Nephew ($SNN), is a strong candidate to replace him, industry watchers say.

- read Sanofi's release (PDF)
- get the results from NEJM
see the earnings call transcript from Seeking Alpha

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